Every finding on record at Parallel Home Care Services, Inc

A Medicare authorized Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 6/25/24 at Parallel home Care Services, Inc, 1600 Mill Creek Court, Marquette, MI 49855. At the conclusion of the survey, the agency was determined to be in compliance with the Conditions of Participation at 42 CFR 484.102.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/25/24 through 6/27/24 at: Parallel Home Care Services, Inc 1600 Mill Creek Court Marquette, MI 49855 This agency has no branches. Clinical records reviewed for this survey included 3 records with home visits, 2 active records without home visits, and 2 discharged records. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 2 of 7 (P-1, 2) patients were included in their overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: **Agency Policy: "Initial Comprehensive Assessment," (Undated). The policy states, "The initial assessment will be made within 48 hours unless otherwise indicated, and will include: m. Frequency and duration of visits.” P-1: The Start of Care (SOC) was dated 3/7/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Colon Cancer and Anemia. During record review on 6/24/24, the signed consent frequencies stated, “Services provided: Skilled Nursing: Eval/treat...” The POC stated, “SN: 2w2 (2 visits a week for 2 weeks), 1w6. The agency failed to provide an accurate written frequency of services to be provided to the patient. P-2: The Start of Care (SOC) was dated 5/14/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Diabetes Type 2 and Chronic Kidney Disease. During record review on 6/25/24, the signed consent frequencies stated, “Services provided: Skilled Nursing: Eval/treat…” The POC stated, “SN: 1w9. The agency failed to provide an accurate written frequency of services to be provided to the patient. These findings were reviewed with and acknowledged by the Staff A (Clinical Manager) during an interview on 6/26/24 at 3:15 pm.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included measurable outcomes and goals specific to the needs of the patient for 7 of 7 records reviewed (P-1, 2, 3, 4, 5, 6, 7), resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: P-1: The Start of Care (SOC) was dated 3/7/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Colon Cancer and Anemia. During record review on 6/24/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt (Patient)/Pcg (Paid care giver) will verbalize measure to manage neurological condition/will be free of unmanaged depression/anxiety symptoms by 5/5/24.” Additionally, another goal stated, “Dyspnea will decrease by 4/6/24.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-2: The Start of Care (SOC) was dated 5/14/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2 and Chronic Kidney Disease. During record review on 6/25/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will be free of signs of CHF exacerbation/signs of CHG exacerbation will be managed at home with use of Furoscix infuser by 7/12/24.” Additionally, another goal stated, “Pt will demonstrate energy conservation techniques by 6/12/24.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-3: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Left Foot Ulcer. During record review on 6/26/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt/Pcg will state understanding of measures to manage disease and identify S/S (Signs and Symptoms) to report by week 4.” Additionally, another goal stated, “Bowel status will be WNL (Within Normal Limits) for patient throughout care and at discharge.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-4: The Start of Care (SOC) was dated 5/16/24. The Plan of Care (POC) identified diagnoses of Pneumonia, Urinary Tract Infection and Left Buttock Pressure Ulcer. During record review on 6/26/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient/Caregiver will verbalize/demonstrate understanding of symptom management, resource utilization and medication management to reduce unplanned hospital or emergency department visits by week 3.” Additionally, another goal stated, “Pt/Pcg will verbalize measure to manage neurological condition by week 4.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. These findings were reviewed with and acknowledged by the Staff A (Clinical Manager) during an interview on 6/26/24 at 3:00 pm. P-5: This 92-year-old patient was admitted to home care on 6/21/24 with diagnoses of hypertensive heart disease with heart failure, type 2 diabetes, and pressure ulcer. During record review on 6/26/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient will state understanding of measures to manage disease and identify signs/symptoms to report. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. P-6: This 91-year-old patient was admitted to home care on 6/29/23 with diagnoses of anemia, osteoarthritis, and atrial fibrillation. During record review on 6/25/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient will demonstrate increased endurance by discharge. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. P-7: This 91-year-old patient was admitted to home care on 9/19/22 with diagnoses of venous insufficiency, chronic non pressure ulcers, and peripheral vascular disease. During record review on 6/24/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient/caregiver will verbalize/demonstrate understanding of symptom management, resource utilization, and medication management to reduce unplanned hospital or emergency department visits. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. These findings were reviewed and acknowledged by the clinical manager (Staff A) during an interview on 6/26/24 at 3:30 p.m. P-5: This 92-year-old patient was admitted to home care on 6/21/24 with diagnoses of hypertensive heart disease with heart failure, type 2 diabetes, and pressure ulcer. During record review on 6/26/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient will state understanding of measures to manage disease and identify signs/symptoms to report. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. P-6: This 91-year-old patient was admitted to home care on 6/29/23 with diagnoses of anemia, osteoarthritis, and atrial fibrillation. During record review on 6/25/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient will demonstrate increased endurance by discharge. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. P-7: This 91-year-old patient was admitted to home care on 9/19/22 with diagnoses of venous insufficiency, chronic non pressure ulcers, and peripheral vascular disease. During record review on 6/24/24, it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, patient/caregiver will verbalize/demonstrate understanding of symptom management, resource utilization, and medication management to reduce unplanned hospital or emergency department visits. There was no evidence of how this goal could be objectively measured to determine progress toward meeting the goal. These findings were reviewed and acknowledged by the clinical manager (Staff A) during an interview on 6/26/24 at 3:30 p.m. P-1: The Start of Care (SOC) was dated 3/7/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Colon Cancer and Anemia. During record review on 6/24/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt (Patient)/Pcg (Paid care giver) will verbalize measure to manage neurological condition/will be free of unmanaged depression/anxiety symptoms by 5/5/24.” Additionally, another goal stated, “Dyspnea will decrease by 4/6/24.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-2: The Start of Care (SOC) was dated 5/14/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2 and Chronic Kidney Disease. During record review on 6/25/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will be free of signs of CHF exacerbation/signs of CHG exacerbation will be managed at home with use of Furoscix infuser by 7/12/24.” Additionally, another goal stated, “Pt will demonstrate energy conservation techniques by 6/12/24.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-3: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Left Foot Ulcer. During record review on 6/26/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt/Pcg will state understanding of measures to manage disease and identify S/S (Signs and Symptoms) to report by week 4.” Additionally, another goal stated, “Bowel status will be WNL (Within Normal Limits) for patient throughout care and at discharge.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-4: The Start of Care (SOC) was dated 5/16/24. The Plan of Care (POC) identified diagnoses of Pneumonia, Urinary Tract Infection and Left Buttock Pressure Ulcer. During record review on 6/26/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient/Caregiver will verbalize/demonstrate understanding of symptom management, resource utilization and medication management to reduce unplanned hospital or emergency department visits by week 3.” Additionally, another goal stated, “Pt/Pcg will verbalize measure to manage neurological condition by week 4.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. These findings were reviewed with and acknowledged by the Staff A (Clinical Manager) during an interview on 6/26/24 at 3:00 pm.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the skilled professionals provided services as ordered by the physician in the plan of care for 1 (P-5) of 7 records reviewed, resulting in the potential for physical decline and unmet care needs for this patient. Findings include: P-5: This 92-year-old patient was admitted to home care on 6/21/24 with diagnoses of hypertensive heart disease with heart failure, type 2 diabetes, and pressure ulcer. During record review on 6/26/24, it was noted that the plan of care ordered nursing to assess/perform/instruct patient/caregiver on blood glucose testing every morning and importance of recording and compliance. The skilled nursing visit on 6/24/24 failed to include a blood glucose level. This finding was reviewed and acknowledged by the clinical manager (Staff A) during an interview on 6/26/24 at 3:30 p.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a discharge summary was complete, provided the patient's current health status at the time of discharge in 1 (P-1) of 2 closed records, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: **Agency Policy: "Discharge Summary," (Undated2023). The policy states, "6 ...The discharge summary will include: g. A summary of the care and services provided." P-1: The Start of Care (SOC) was dated 3/7/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Colon Cancer and Anemia. During record review on 6/24/24, it was noted that the Skilled Nursing Discharge Summary dated 5/2/24 stated, "Care Summary (care given, intervention, progress, regress including therapies): Pasted into this area is a list of the interventions from the POC. The discharge summary failed to detail the course of care provided, responses to treatment and any potential continuing needs. These findings were reviewed with and acknowledged by the Staff A (Clinical Manager) during an interview on 6/26/24 at 3:30 pm.

A Medicare authorized complaint investigation was conducted by the Michigan Department of Licensing and Regulatory Affairs from 3/4/24 to 3/5/24 at: Parallel Home Care Services 1600 Mill Creek Court Marquette, MI 49855 At the conclusion of the survey, the agency was found to be out of compliance, at the standard level, with the conditions of participation at 42 CFR§484, Home Health Care.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to contact the physician in 1 of 6 records reviewed (P-5) for falls, from a total of 10 records reviewed, resulting in the potential for unresolved healthcare concerns. Findings include: P-1: This 80-year-old patient was admitted to home health care on 8/24/2023, with diagnoses of pressure ulcer of right buttock, pressure ulcer of right elbow, and venous insufficiency. During review of the agency’s “Fall and Infection Log” on 3/5/2024, three patient entries were discovered regarding P-5, all signed by Registered Nurse (Staff-A) and dated 1/18/2024. The patient fell on 1/17/2024. Staff-A documented the fall on a “Report of Incident” form dated 1/18/2024. The “Report of Incident” form documented the patient fell with bleeding and possible further splitting of right elbow.” During an interview at 2:20 p.m. on 3/5/2024., the clinical manager (Staff-B) was questioned about communication with the assisted living facility regarding the fall. Staff-B provided a phone call narrative signed by Staff-A dated 1/17/2024 at 11:32 a.m., that stated at 7:37 a.m., on 1/17/2024, “The patient fell and there is a lot of blood on right elbow, and it looks like patient needs stitches. Instructed on wound care and planned visit for today and notified power of attorney (POA).” A second phone call narrative signed by Staff-A dated 1/17/2024 at 11:35 a.m., stated at 11:00 a.m. on 1/17/2024, “The patient fell again, communicated with POA and she states she will come and get patient and take him to the emergency room for possible sutures to right elbow and evaluation.” During the 2:20 p.m., interview on 3/5/2024, Staff-B was questioned about communication with the patient’s physician regarding the falls and injury. Staff-B said there is no documentation that the patient’s physician was notified on 1/17/2024 of the patient’s falls and injury. On 3/5/2024, the agency’s Adverse Events/Incidents and Unusual Occurrences Policy (2.82) pages 185-188, was reviewed. The policy classifies a patient injury (Fall) as an Adverse Event (Pages 185-186). The policy indicates (Page 188), “With Adverse Events: The MD will be notified in the event of patient injury or death. This notification will be documented on the Incident Report.” The patient’s Incident Reports dated 1/18/2024 did not have any physician notification documented, as required by the agency’s policy. The policy also states on page 185, paragraph 2, “Staff members are educated in the proper response to an unexpected event, injury or exposure.” On 3/5/2024, Staff-A employee training Education/Inservice sheets dated 8/13/2020-10/30/23, were reviewed and were found to be in compliance with policy (2.82) page 185, paragraph 2. These findings were reviewed with and acknowledged by the clinical manager (Staff-B) during an interview on 3/5/2024 at 3:30 p.m.

The following condition level deficiencies were identified at a Medicare authorized Re-Certification survey, concurrent with a Focused Infection Control Covid-19 Emergency Preparedness survey, by the Michigan Department of Licensing and Regulatory Affairs on 6/29/21 through 7/1/21 at: Parallel Home Care Services 1600 Mill Creek court Marquette, MI 49855 The agency had no additional extension sites. At the survey's conclusion, the agency was found to be non-compliant with the regulatory requirements at 42 CFR §484.102 Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on interview and record review, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated to include strategies to address the Covid-19 global pandemic, resulting in no directions for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all 43 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to develop an Emergency Preparedness Plan that was based on a community and facility-based risk assessment from an all hazards approach and failed to include strategies in its plan for the identified risks, including the Covid-19 virus, resulting in the potential for staff to be ill-prepared in the event of a crisis or disaster and the potential for negative outcomes for all 43 patients currently serviced by this agency (E0006); failed to develop and establish written Emergency Preparedness policies and procedures that were based on the Emergency Preparedness plan, risk assessment and communication plan that had been updated to include strategies for the global Covid-19 pandemic, resulting in the agency's inability to implement appropriate emergency actions and potential poor outcomes for all staff employed by this agency and the 43 patients currently serviced (E0013); failed to ensure all staff, including contract personnel, received initial and bi-annual training in the Agency's Emergency Preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice could potentially affect staff and all 43 patients currently serviced by this Agency (E0037); failed to provide documentation for the required table top exercise, community based full-scale exercise or any documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff is not being properly prepared for an actual emergency. This deficiency has the potential to affect staff and all 43 patients currently serviced by this agency, in the event of an actual disaster (E0039). The cumulative effect of these systemic problems could potentially negatively affect all patients of the home health agency in the event staff is not properly prepared for an emergency for the condition of participation of 42 CFR §484.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. This STANDARD is not met as evidenced by: Based on interview and record review, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated to include strategies to address the Covid-19 global pandemic, resulting in no directions for Agency personnel in the event of an actual emergency or disaster. This deficient practice could negatively affect the health and safety of all 43 patients actively serviced by this agency in the event of an emergency or disaster. Findings include: On 7/1/21 at 10:25 a.m., during a review of the agency's Emergency Preparedness documents with Clinical Manager (CM #1), it was noted that there was no documentation that showed the agency had developed an emergency preparedness plan that was reviewed/updated to include strategies to address the Covid-19 pandemic. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. *[For LTC facilities at §483.73(a)(1):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a)(1):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a)(2):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. This STANDARD is not met as evidenced by: Based on interview and record review, the Agency failed to develop an Emergency Preparedness Plan that was based on a community and facility-based risk assessment from an all hazards approach and failed to include strategies in its plan for the identified risks, including the Covid-19 virus, resulting in the potential for staff to be ill-prepared in the event of a crisis or disaster and the potential for negative outcomes for all 43 patients currently serviced by this agency. Findings include: On 7/1/21 at 10:25 a.m., during a review of the agency's Emergency Preparedness documentation with the Clinical Manager (CM #1), it was noted that the agency's risk assessment was blank. There was no evidence that the facility conducted a risk assessment utilizing an all-hazards approach with regards to natural, man-made, facility and geographic related emergencies with the inclusion of the Covid-19 global pandemic. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

Development of EP Policies and Procedures CFR(s): 484.102(b) (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and establish written Emergency Preparedness policies and procedures that were based on the Emergency Preparedness plan, risk assessment and communication plan that had been updated to include strategies for the global Covid-19 pandemic, resulting in the agency's inability to implement appropriate emergency actions and potential poor outcomes for all staff employed by this agency and the 43 patients currently serviced. Findings include: On 7/1/21 at 10:45 a.m., the agency's Emergency Preparedness policy, with the inclusion of strategies for the Covid-19 global pandemic, was requested for review. Of the documents provided by the Clinical Manager (CM #1), who was present during the review, there was no documented evidence that an Emergency Preparedness Policy existed that included the requirements of this section. During the interview, CM #1 reported, "I know we discussed it (Covid-19), however, I don't see anything in writing."

EP Training Program CFR(s): 484.102(d)(1) *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure all staff, including contract personnel, received initial and bi-annual training in the agency's Emergency Preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice could potentially negatively affect staff and all 43 patients currently serviced by this Agency. Findings include: On 7/1/21 at 10:25 a.m., the agency's Emergency Preparedness documentation was reviewed with the Clinical Manager (CM #1) present. Upon review, there was no documented evidence that all Agency staff, including contract personnel, had received initial or bi-annual training in emergency preparedness as required as of January 2018. Additionally, there was no documentation that indicated staff had been tested on their knowledge of information received in training/testing. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

EP Testing Requirements CFR(s): 484.102(d)(2) *[For RNCHI at §403.748, ASCs at §416.54, HHAs at §484.102, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHC at §485.920, RHC/FQHC at §491.12, ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d) (2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency failed to provide documentation for the required table top exercise, community based full-scale exercise or any documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff is not being properly prepared for an actual emergency. This deficiency has the potential to negatively affect staff and all 43 patients currently serviced by this agency, in the event of an actual disaster. Findings include: On 7/1/21 at 10:35 a.m., the Clinical Manager CM #1 was queried about annual full-scale community-based emergency preparedness exercises, or tabletop exercises and stated, "We conducted some drills." Adm #1 provided documents that included topics such as, Fire Drill and Severe storm. The documents had check marks on it and it was unclear as to who participated in the drills. Adm #1 was unable to provide evidence of the required exercises for this requirement.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/29/2021 through 7/1/2021 at: Parallel Home Care Services 1600 Mill Creek Court Marquette, MI 49855 At the time of the survey, the agency did not operate any branch offices or subunits. Clinical records reviewed for this survey included 3 records with home visits, 4 records without home visits which included 2 discharge records and 3 active records for a total of 7 records reviewed. Condition level deficiencies were identified at: 42 CFR §484.50 Patient Rights 42 CFR §484.55 Comprehensive Assessment of Patients 42 CFR §484.60 Care Planning, Coordination, Quality of Care 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR §484.70 Infection Prevention and Control 42 CFR §484.102 Emergency Preparedness As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on observation, interview and record review, the agency failed to provide documented evidence that patients received and understood the written notice of patient's rights, responsibilities, and the agency's transfer and discharge policies in advance of furnishing care for 4 (MR#s 1, 2, 4, 5) of 7 sampled records reviewed, resulting in lack of informed consent (G412); failed to provide documented evidence that the patient or their family/representative was informed of their rights and failed to provide evidence that the patient's family/representative's signature had been obtained confirming receipt of the patient rights in 2 of 7 sampled records reviewed, resulting in the patient/representative not being fully informed of their rights (G418); failed to ensure that 2 (MR's #4 and 4) of 7 sampled patients reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, resulting lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs (G434); failed to inform the patient/caregiver, orally and in writing, before care was initiated of the extent to which payment for home health agency services may be expected from Medicare or other funding sources and the extent to which payment may be required from the patient in 2 (MR# 4, 5) of 7 sampled records reviewed, resulting in the potential for unauthorized and undisclosed charges (G440); failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 1 (MR# 6) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end covered services, and the potential for unmet care needs (G442). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.50 Patient Rights.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to provide documented evidence that patients received and understood the written notice of patient's rights, responsibilities, and the agency's transfer and discharge policies in advance of furnishing care for 4 (MR#s 1, 2, 4, 5) of 7 sampled records reviewed, resulting in lack of informed consent. findings include: MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included stroke with right sided weakness. On 6/29/21 at 12:45 p.m., a joint survey home visit with the Speech Therapist (ST) was conducted. During the visit, the patient's admission packet was reviewed. All documents (consent for treatment, advanced directives...) were noted to be blank. There was no patient or discipline consent that acknowledged receipt or review of the information as per this requirement. No consents or any documents related to patient rights had been made available for review by the surveys end. These findings were reviewed with the clinical Manager (CM #1) during an interview on 6/29/21 at 3:00 p.m. who reported, "The Nurse (RN #1) didn't complete the documents. I spoke with her and she said she would, but it hasn't been done yet." MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. During the clinical record review on 6/30/21 at 9:35 a.m., it was noted that there were no consent forms or any forms that acknowledged the patient was made aware of patient rights. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 9:43 a.m. CM #1 looked through the electronic medical record (EMR) and reported, "I'm looking in the record and it's not there." MR #1: The start of care (SOC) was dated 6/1/21 with diagnoses that included right femur fracture, Parkinson's disease, aphasia, and congestive heart failure. During a survey home visit on 6/29/21, it was observed while reviewing the patient's admission packet from the home health agency, that "Consent for Treatment and Financial Agreement, Advanced Directive Acknowledgement/HIPPA/Home Care Privacy Rights Acknowledgement, Patient Emergency and Contact Information, Home Safety Assessment, and Your Plan for Home Health" forms were all blank. The patient was queried about completing the forms within the packet during the start of care visit on 6/1/21 (4 weeks). The patient replied, "I think all that stuff was filled out, but I'm not sure where's it at." MR #2: The SOC for this patient was dated 4/19/21 with diagnoses that included surgical wound care, chronic pain, and major depressive disorder. During a survey home visit on 6/30/21, it was observed while reviewing the patient's admission packet from the home health agency, that "Consent for Treatment and Financial Agreement, Advanced Directive Acknowledgement/HIPPA/Home Care Privacy Rights Acknowledgement, Patient Emergency and Contact Information, Home Safety Assessment, and Your Plan for Home Health" forms were again found to be all blank. The patient was queried about completing the forms within the packet during the start of care visit on 4/19/21 (10 weeks). The patient replied, "Yeah, I remember filling those out, I think I was supposed to get copies back but haven't yet." During an interview with the Clinical Manger (CM#1) on 6/30/21 at 10:50 AM, it was queried why the patient admission packets for MR's #1 and 2 were essentially blank. CM #1 responded, "We have the originals to upload into our records and then try to return them in a week or so." CM #1 acknowledged the findings and agreed that a "better system" needs to be utilized going forward.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined the Agency failed to provide documented evidence that the patient or their family/representative was informed of their rights and failed to provide evidence that the patient's family/representative's signature had been obtained confirming receipt of the patient rights in 2 (MR#'s 4, 5) of 7 sampled records reviewed, resulting in the patient/representative not being fully aware of their rights. Findings include: MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included stroke with right sided weakness. On 6/29/21 at 12:45 p.m., a joint survey home visit with the Speech Therapist (ST #1) was conducted. During the visit, the patient's admission packet was reviewed. All documents (consent for treatment, advanced directives...) were noted to be blank and void of any signatures. There was no patient or discipline signed consent that acknowledged receipt or review of the information as per this requirement. No consents or any documents related to patient rights had been made available for review by the surveys end. Upon completion of the visit, ST #1 confirmed, "The admission documents are blank." These findings were reviewed with the clinical Manager (CM #1) during an interview on 6/29/21 at 3:00 p.m. who reported, "The Nurse (RN #1) didn't complete the documents. I spoke with her and she said she would but it hasn't been done yet." MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. During the clinical record review on 6/30/21 at 9:35 a.m., it was noted that there were no consent forms or any forms that acknowledged the patient was made aware of patient rights. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 10:00 a.m.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure that 2 (MR's #4 and 5) of 7 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included stroke with right sided weakness. On 6/29/21 at 12:45 p.m., a joint survey home visit with the Speech Therapist (ST) was conducted. During the visit, the patient's admission packet was reviewed. All documents (consent for treatment, calendar, advanced directives...) were noted to be blank. These findings were reviewed with the clinical Manager (CM #1) during an interview on 6/29/21 at 3:00 p.m. who reported, "The Nurse (RN #1) didn't complete the documents. I spoke with her and she said she would but it hasn't been done yet." MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. During the clinical record review on 6/30/21 at 9:35 a.m., it was noted that there were no admission documents, including a calendar of proposed visits, available for review. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 10:00 a.m.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to provide documented evidence that the patient/caregiver were informed orally and in writing, before care was initiated, of the extent to which payment for home health agency services may be expected from Medicare or other funding sources, and the extent to which payment may be required from the patients in 2 (MR# 4, 5) of 7 sampled records reviewed, resulting in the potential for unauthorized and undisclosed charges. Findings included: MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included stroke with right sided weakness. On 6/29/21 at 12:45 p.m., a joint survey home visit with the Speech Therapist (ST) was conducted. During the visit, the patient's admission packet was reviewed. All documents (consent for treatment, expected payment amount, cost for skilled services, advanced directives...) were noted to be blank. There was no patient or discipline signed consent that acknowledged receipt or review of the information as per this requirement. No completed documents had been provided for review by the end of the survey. These findings were reviewed with the clinical Manager (CM #1) during an interview on 6/29/21 at 3:00 p.m. who reported, "The Nurse (RN #1) didn't complete the documents. I spoke with her and she said she would but it hasn't been done yet." MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. During the clinical record review on 6/30/21 at 9:35 a.m., it was noted that there were no consent forms or any forms that acknowledged the patient was made aware of patient rights or payment responsibilities. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 10:00 a.m.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 1 (MR# 6) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end covered services, and the potential for unmet care needs. Findings include: MR #6: The patient's start of care (SOC) was 12/12/20 with diagnoses that included insulin dependent diabetes mellitus, epilepsy and gastroparesis. The record review, conducted on 6/30/21 at 11:30 a.m., revealed the following: The plan of care (POC) ordered Skilled Nursing (SN) services to be provided. The patient discharged from the agency's services on 12/31/20. There was no documented evidence that the patient was provided the "Notice of Medicare Provider Non-Coverage" prior to being discharged from the agency. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. The above findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 7/1/21 at 9:49 a.m.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to incorporate pertinent baseline information from the referral in 1 (MR #3) of 7 records reviewed, resulting in a poor patient outcome, and failed to ensure the comprehensive assessment included baseline information detailing the patient's current health at the time of admission for 7 of 7 (MR's #1, 2, 3, 4, 5, 6, and 7) records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients and for measuring the patient's progress toward goals/outcomes (See G 528); and failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review, and failed to ensure the Physician was notified of potential drug interactions in 3 (MR#'s 4, 6, and 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency (See G 536). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.55 Comprehensive Assessment of Patients.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on document review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 7 of 7 (MR's #1, 2, 3, 4, 5, 6, and 7) records reviewed, resulting in incomplete clinical information and a poor outcome towards determining the needs of these patients and for measuring the patient's progress toward goals/outcomes. Findings include: MR#3: This patient had a start of care (SOC) date of 10/16/20, which included diagnoses of chronic obstructive pulmonary disease (COPD), Sarcopenia (degenerative muscle loss), and hypertensive heart disease with failure. During record review on 7/1/21, the referral for home care dated 10/15/20, documented physician orders for "Oxygen 3 L/min continuous active 9/2/20, Pulse ox (check oxygen levels) every shift, change oxygen tubing weekly and PRN (as needed), rinse oxygen concentrator filter weekly and PRN." The referral also documented a hospital admission on 6/20/20 for acute respiratory failure related to COPD. In addition, an order for cardiac diet due to heart failure was noted. Review of the SOC assessment completed by RN #1, dated 10/16/20 under section M1400 for respiratory and cardiac status, had no prior history or oxygen needs identified. No history of the patient's heart failure was documented. In addition, all identified diagnoses (13 total) found under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date. Further review of the entire comprehensive assessment noted failure to document dates of exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care. Documentation of a skilled nursing visit one week after the SOC by RN #1 (dated 10/23/20) documented the following: "Pt (patient) put on continuous O2 (oxygen) permanently after pt had episode of de-sating causing trip to ER earlier this week."(sic). No oxygen treatments/interventions were identified in the medical record prior to the patient having to go to the ER for low oxygen despite the physician order on the referral for oxygen at 3 liters/minute continuously and documentation of a hospital admission on 6/20/20 for respiratory failure. A discharge OASIS (Outcome and Assessment Information Set) dated 11/4/20 noted goals were met, and patient was medically stable. However, no documentation concerning the ER admission was found. The patient was re-admitted to home care on 11/13/20 following hospitalization on 11/9/20 through 11/11/20 due to respiratory and heart failure. The SOC assessment completed by RN #2 on 11/13/20, identified diagnoses (16 total) which now included acute and chronic respiratory failure with hypoxia and hypertensive heart disease with failure. All 16 diagnoses under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date (11/13/21). Further, under "Respiratory Status" RN#2 documented the patient was short of breath at rest, and "Diminished lung sounds and wheezing heard throughout." No documentation was found concerning if the patient was on oxygen and at what rate, or if the nurse ever assessed the patient's oxygen level. No information regarding dates of exacerbation, prior treatments, outcomes, or history relating the 16 identified diagnoses were found. Further review of the comprehensive assessment noted the agency's failure to document any information/treatments concerning the recent hospitalization. The hospital discharge summary (dated 11/11/20) which was available to RN #2 at the SOC, noted pertinent findings not found within the SOC assessment. The discharge summary documented, "This 83 year old male with acute chronic hypoxic respiratory failure due to acute and chronic combined CHF (congestive heart failure) exacerbation who has been admitted the last two days for diuresis after he presented to this PCP office with a resting O2 sat of 85%...at baseline uses 3 liters per minute of oxygen 24/7. He also had significant pitting edema, tachycardia, and a weight gain of 14 lbs. compared to his last appointment... echocardiogram done recently in 9/2020 that showed severely reduced left EF (ejection fraction is ability for the heart to pump blood) of 30-35% and at least grade 2 diastolic dysfunction." A transfer OASIS on 11/18/21 documented, "Pt send out to ER r/t Signs/Symptoms of infection. Pt was SOB (short of breath) and and wanted to go to the hospital as well." (sic) No additional information or follow-up regarding the patient's health status was found. During an interview on 7/1/21 at 12:10 PM, the Clinical Manager (CM #1) acknowledged the findings and stated, "This is unacceptable, I will make sure this doesn't happen again." MR#1: The Start of Care (SOC) was dated 6/1/21. During record review on 6/30/21, the Comprehensive or SOC assessment identified diagnoses (15 total) which included right femur fracture, Parkinson's disease, aphasia, and congestive heart failure. All 15 diagnoses under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date. Further review of the comprehensive assessment noted failure to document dates of exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care. During an interview on 7/1/21 at 11:40 AM, the Clinical Manager (CM #1) acknowledged the findings and stated, "I agree, the overall history for this patient is lacking." MR#2: The SOC for this patient was dated 4/19/21. During record review on 6/30/21, the SOC assessment identified diagnoses (7 total) which included surgical wound care, chronic pain, and major depressive disorder. All 7 diagnoses under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date. Additional review of the comprehensive assessment failed to document dates of exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care. CM #1 acknowledged the findings during an interview on 7/1/21 at 11:55 AM. MR 4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included CVA (stroke) with dysphagia (difficulty swallowing), right sided weakness and hypertension. The clinical record review was conducted on 6/29/21 at 4:00 p.m. The Initial Comprehensive Assessment dated 6/24/21 completed by the Registered Nurse (RN #1) revealed the following: Sections 1021/1023 titled (Primary/Other Diagnoses) were left blank. The section titled, "Neuro/emotional/cognitive status" documented "Alert/oriented, Never confused." However, in the following section titled "Mental Status", RN #1 documented the patient was both "forgetful and oriented" with an onset date of 6/24/21. The assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 7/1/21 at 4:15 p.m. MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. The clinical record review was conducted on 6/30/21 at 9:35 a.m. The Initial Comprehensive Assessment dated 6/11/21 completed by the Registered Nurse documented: Sections 1021/1023 listed primary and other diagnoses of "diabetes mellitus, heart failure, chronic kidney disease, muscle weakness, major depressive disorder, glaucoma history of falls..." All the listed diagnoses had an onset/exacerbation date of 6/11/21. Section M1028 listed Diabetes Mellitus as an "Active Diagnosis", however the section titled, "Endocrine" was void of a baseline blood glucose reading. Section M1033/Functional Level documented, "Unintentional weight loss..." The section titled "Nutritional Status" indicated "Good nutritional status." The comprehensive assessment was inconsistent and failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 9:43 a.m. MR #6: The patient's SOC was 12/12/20 with diagnoses that included diabetes mellitus, epilepsy, nausea and vomiting. The clinical record review was conducted on 6/30/21 at 11:30 a.m. The Initial Comprehensive Assessment dated 12/12/20 completed by the Registered Nurse revealed: Sections 1021/1023 Primary/Other diagnoses listed diagnoses such as diabetes mellitus, epilepsy, nausea/vomiting... None of the 10 listed diagnoses had dates of onset or exacerbation. Diabetes Mellitus was listed as an Active Diagnosis, however the section titled "Endocrine" offered no baseline blood glucose level. The comprehensive assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 9:49 a.m. MR #7: The patient's SOC was 5/17/21 with diagnoses that included pressure sore right/left buttocks, acute respiratory failure and pulmonary fibrosis. The clinical record review was conducted on 6/30/21 at 3:30 p.m. The Initial Comprehensive Assessment dated 5/17/21 completed by the Registered Nurse revealed: Section 1021/1023 listed primary and other diagnoses such as of pressure ulcer right/left buttock, acute respiratory failure, pulmonary fibrosis, alkalosis, hypertensive heart disease with heart failure... All the patient's 26 listed diagnoses had an onset/exacerbation date of 5/17/21. The section titled, "Integumentary Status" displayed a diagram to describe the location of the wounds. The nurse failed to indicate whether the wounds (pressure sores) were on the patient's Left or Right buttock. The comprehensive assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. The findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 10:11 a.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of potential drug interactions in 3 (MR's # 4, 6, 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all 43 patients currently serviced by this Agency. Findings include: Policy: "Medication Profile" 2.54, undated stated, "The comprehensive assessment includes a review of all medications the patient is currently using, both prescription and non-prescription..., in therapy only cases, the therapist submits a list of medications, collected during the comprehensive assessment, to the RN for review..., identify actual or potential drug interactions, duplicate drug therapy, non-compliance..., Any problems identified, will be promptly reported to the physician and documented in the clinical record..., The medication profile lists drug classifications, must contain current medications, date prescribed/started, name of medications, dose and frequency, route, allergies, potential side effects..., A medication profile will be filled out upon initial evaluation of each patient/client. A copy is kept in the patient/client home and updated as personnel are made aware of any changes." MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included stroke with right sided weakness and essential hypertension. On 6/29/21 at 4:00 p.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 6/24/21, completed by the Registered Nurse (RN #1), indicated "No issues found during review." Further review revealed that RN #1 had not listed any medications to be reviewed. Additionally, during a joint survey home visit with the Speech Therapist (ST #1) on 6/29/21 at 12:45 p.m., there was no Medication Profile that lists all the patients medications, frequency and side effects, left in the patient's home. There was no documented evidence that RN #1 had conducted a comprehensive drug review in order to identify any untoward drug interactions. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 7/1/21 at 9:16 a.m. who reported, "I'm wondering how she (RN #1) would know there were no interactions if there were no meds listed." MR #6: The patient's SOC was 12/12/20 with diagnoses that in included insulin dependent diabetes mellitus, epilepsy and gastroparesis. During the record review on 6/30/21 at 11:30 a.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 10/16/20, completed by the Registered Nurse, indicated "No issues found during review." The patient's 13 prescribed medications were entered into "Drugs.com" (online drug interaction checker) and revealed: 8 moderate drug to drug interactions, 7 drug to food interactions and 1 duplicate drug. There was no documented evidence that the agency conducted a comprehensive drug review in order to identify any untoward drug interactions and no evidence that the Physician had been notified as indicated in the agency's policy. These findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 9:49 a.m. MR #7: The patient's SOC was 5/17/21 with diagnoses that in included pressure sore to right and left buttock, and acute respiratory failure. During the record review on 6/30/21 at 3:30 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 10/16/20, completed by the Registered Nurse, indicated "No issues found during review." CM #1 was asked to conduct a drug review using the agency's electronic medical records (EMR) system. On 6/30/21 at 4:25 p.m., CM #1 presented a document titled, "Drug Interaction Results." Of the patient's 27 prescribed/listed medications the following interactions were noted: 1 moderate drug to drug interaction, 3 minor drug to drug interactions and 3 duplicate drugs. There was no documented evidence that the agency had conducted a comprehensive drug review in order to identify any untoward drug interactions, and no evidence that the Physician had been notified in accordance with the agency's policy. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the plan of care included objectively measurable and individualized goals in 3 of 7 records reviewed (MR#'s 1, 2, and 3) with skilled nursing ordered out of a total of 7 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes (See G 572); failed to ensure the plan of care included pertinent treatment/interventions in 4 of 7 records (MR#'s 3, 4, 5, 6) from a total of 7 records reviewed, resulting in a poor outcome (See G 574); and failed to ensure that treatment/interventions were provided only in accordance with physician's orders for 1 of 7 records (MR #3) out of a total of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs (See G 580). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care Planning, Coordination, Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the plan of care included objectively measurable and individualized goals in 3 of 7 records reviewed (MR#s 1, 2, and 3) with skilled nursing ordered out of a total of 7 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes. Findings include: MR#1: The start of care (SOC) for this patient was dated 6/1/21. The plan of care (POC) identified diagnoses which included right femur fracture, Parkinson's disease, aphasia, and congestive heart failure. During record review on 6/30/21, it was noted that the skilled nursing (SN) goals on the POC were not measurable (9 of 9), for example: "Pt (patient) wants to be able to resume prior level of function like walking through the neighborhood with her lady friends, Goals: 10%, Patient will demonstrate increased endurance by 8 weeks, Goals: 10%, Pt will be free from injury by 8 weeks, Goals: 10%." The Clinical Manager (CM #1) was queried during an interview on 7/1/21 at 11:40 AM the following question. What is SN measuring 10% of, and why is each goal at 10%? After thinking for a moment, CM #1 responded, "I see your point, each 10% goal pertains to something that isn't measurable the way it's written, and I don't know why 10% was chosen for every goal." There was no evidence of how these goals could be quantitatively measured. MR#2: The patient's SOC was 4/19/21 and re-certified on 6/18/21. The POC included diagnoses of surgical wound care, chronic pain, and major depressive disorder. During record review on 6/30/21, it was noted that the SN goals on the POC were not measurable (8 of 8), for example: "Pt will be free from injury by (blank) discharge, Pt/Pcg (primary care giver) will verbalize measure to manage neurological condition by (blank) discharge, Patient/Caregiver will verbalize/demonstrate understanding of symptom management, resource utilization and medication management to reduce unplanned hospital or emergency department visits by (blank) discharge. There was no evidence of how these goals could be quantitatively measured. MR#3: This patient had a SOC date of 10/16/20, which included diagnoses of chronic obstructive pulmonary disease (COPD), Sarcopenia (degenerative muscle loss), and hypertensive heart disease with failure. During record review on 7/1/21, it was noted that the SN goals on the POC were not measurable (8 of 8), for example: "Patient-Centered Goal(s): (blank) continue to regain strength to be as independent as possible, Progress Towards Goals: 100%, Pt will demonstrate increased endurance by 60 days, Progress Towards Goals: 100%. All goals were listed at 100% for intended progress with no evidence of goals being written in measurable terms.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on document review and interview, the agency failed to ensure the plan of care included all pertinent interventions for 4 (MR's #3, 4, 5, 6) of 7 records reviewed, resulting in the patient not receiving care based on specific individual needs and a poor patient outcome. Findings include: Agency Policy: "Care Plan" 2.8 (dated 2018) stated, "Steps to be taken in developing the care plan include: Collection of baseline data including all pertinent diagnoses... identification of any services furnished by other providers... equipment required. What measures are required for comfort, safety, prevention of complications?" MR#3: This patient had a SOC date of 10/16/20, which included diagnoses of chronic obstructive pulmonary disease (COPD), Sarcopenia (degenerative muscle loss), and hypertensive heart disease with failure. During record review on 7/1/21, the referral for home care dated 10/15/20, documented physician orders for "Oxygen 3 L/min continuous active 9/2/20, Pulse ox (check oxygen levels) every shift, change oxygen tubing weekly and PRN (as needed), rinse oxygen concentrator filter weekly and PRN." The referral also documented a hospital admission on 6/20/20 for acute respiratory failure related to COPD. In addition, an order for cardiac diet due to heart failure was noted. The plan of care (POC) ordered skilled nursing (SN) on 10/16/20 home visits at a frequency of 1w1, 2w8 (twice a week times 8 weeks), physical therapy to evaluate and treat, and occupational therapy to evaluate and treat. Review of the POC completed by RN #1 dated 10/16/20, failed to incorporate any oxygen interventions, either continuous or as needed. No treatments or interventions to monitor the patient's heart failure (weight, limb circumference measurements, or lung sounds) were noted. Documentation of a skilled nursing visit one week after the SOC by RN #1 (dated 10/23/20) documented the following: "Pt (patient) put on continuous O2 (oxygen) permanently after pt had episode of de-sating causing trip to ER earlier this week." No oxygen treatments/interventions were identified in the medical record prior to the patient having to go to the ER for low oxygen despite the physician order on the referral for oxygen at 3 liters/minute continuously and documentation of a hospital admission on 6/20/20 for respiratory failure. A discharge OASIS (Outcome and Assessment Information Set) dated 11/4/20 noted goals were met by all disciplines, and the patient was medically stable. However, all SN visit notes failed address or monitor the patient's heart failure status prior to discharge on 11/4/20 due to the POC not having any interventions to do so. The patient was re-admitted to home care on 11/13/20 following hospitalization on 11/9/20 through 11/11/20 due to respiratory and heart failure. The hospital discharge summary dated 11/11/20, documented the following outcome: "This 83 year old male with acute chronic hypoxic respiratory failure due to acute and chronic combined CHF (congestive heart failure) exacerbation who has been admitted the last two days for diuresis after he presented to this PCP office with a resting O2 sat of 85%... at baseline uses 3 liters per minute of oxygen 24/7. He also had significant pitting edema, tachycardia, and a weight gain of 14 lbs. compared to his last appointment... echocardiogram done recently in 9/2020 that showed severely reduced left EF (ejection fraction/ability for the heart to pump blood) of 30-35% and at least grade 2 diastolic dysfunction." During an interview on 7/1/21 at 12:10 PM, the Clinical Manager (CM #1) acknowledged the findings and stated, "This is unacceptable, I will make sure this doesn't happen again." The Agency failed to ensure the patient's POC incorporated pertinent clinical findings/equipment to help prevent complications as stipulated by Agency policy. MR #4: The patient's SOC was 6/24/21 with diagnoses that included CVA (stroke) with right sided weakness, dysphagia (difficulty swallowing) an essential hypertension. During the clinical record review on 6/29/21 at 4:00 p.m., and again on 6/30/21 at 9:00 a.m., it was noted that the POC ordered Skilled Nursing (SN), Physical Therapy (PT) and Speech Therapy (ST) services to be provided. The POC was bare and only included interventions and goals for ST. The POC was void of any other information including SN interventions, reportable parameters and measurable goals. Additionally, the POC was void of the patient's medications, DME (durable medical equipment), supplies, safety measures, nutritional requirements, allergies, limitations, activities, mental status, and prognosis. The Plan of Care failed to include all the required elements, as per this requirement, in order to meet the individualized needs of the patient. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) on 6/29/21 at the time of discovery who reported, "The nurse (RN #1) should have at least listed the medications. We were waiting for the coder before finalizing the Plan." The required elements still had not been added to the patient's POC by the end of the survey on 7/1/21. MR #5: The patient's SOC was 6/11/21 with diagnoses that included diabetes mellitus, chronic kidney disease and weakness. During the record review on 6/30/21 at 9:35 a.m., it was noted that the Initial Comprehensive Assessment dated 6/11/21 completed by the Registered Nurse, documented, "Unintentional weight loss of a total of 10 pounds or more...", with a reported weight of 140 pounds. The POC failed to include interventions to weigh the patient on a consistent schedule with reportable parameters, and failed to include patient teaching regarding maintaining a weight log. The comprehensive assessment documented that the patient was to be on a "Diabetic Diet", however, the POC indicated "Low Sodium diet." Additionally, the POC had no frequency for when the patient's blood sugars would be checked. The SN goals were not measurable and stated, "blood sugar will be within physician established parameters..." The Plan of Care failed to include individualized treatment/services with reportable parameters and measurable goals in order to meet the needs of the patient. These findings were reviewed with and confirmed by CM #1 during an interview on 7/1/21 at 9:43 a.m. MR #6: The patient's SOC was 12/12/20 with diagnoses that included insulin dependent diabetes mellitus, epilepsy, nausea and vomiting and gastroparesis. During the record review on 6/30/21 at 11:30 a.m., it was noted that the POC documented, "Vital sign parameters, Notify Physician if: Blood Glucose is greater than 425..." (No baseline glucose level had been obtained at the SOC). There was no frequency in which the blood sugars should be checked. The patient's Hospital Discharge paperwork dated 12/11/20, revealed the patient's average blood glucose levels were "168, 207, 210, 173..." The normal blood glucose levels for the diabetic patient can average 126 - 200. The set parameters failed to encompass the individualized needs of the patient. These findings were reviewed with and confirmed by CM #1 during an interview on 7/1/21 at 9:49 a.m. who reported, "I've talked to the staff about parameters, to make them more individualized."

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided only as ordered by the physician in 1 of 7 (MR #1) records reviewed, resulting in the potential to negatively affect all 43 patients currently serviced by the agency. Findings include: MR#3: This patient had a SOC date of 11/13/20, which included diagnoses of acute and chronic respiratory failure with hypoxia and hypertensive heart disease with failure. The plan of care (POC) ordered skilled nursing (SN) on 11/13/20 home visits at a frequency of 2w2 (twice a week times 2 weeks) and have SN monitor for weight gain of 3 lbs. or more in a day to assess any exacerbations of heart failure. Review of the first SN visit note (11/16/20) after the SOC visit noted a failure to document the patient's weight as ordered. On 11/18/20, the patient was transferred to the emergency room for signs and symptoms of infection and shortness of breath (SOB). The clinical record had no follow-up information to ascertain if the SOB was attributed to heart failure exacerbation. This finding was reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 12:10 PM.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (See G 642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (See G 644); failed to document the quality improvement projects for 2020 and 2021 to date, and document the reasons for conducting these projects and the measurable progress achieved each year (See G 658); and failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section (See G 660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency has served for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 154 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The agency's Quality Assessment and Performance Improvement (QAPI) documentation was reviewed on 7/1/21. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program but had no additional documentation or data since 2019. The Clinical Manager (CM #1) was questioned regarding QAPI indicators and process to measure on 7/1/21 at 11:05 AM and stated, "I'm afraid we don't have anything since 2019. I wasn't here then, but I will make sure this is addressed going forward."

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement program, which had the potential to negatively affect all 154 patients serviced by the agency during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During an interview on 7/1/2021 at 11:05 AM, a request was submitted to review the QAPI (quality assessment performance improvement) documents for the last 3 years concerning the evaluation of relevant program data. The Clinical Manager (CM #1) was unable to produce any documentation since 2019. CM #1 stated, "We've worked on this, but we don't have anything that's formal and signed off on."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for 2020 and 2021 to date, resulting in the agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: During an interview on 7/1/21 at 11:05 AM, the Clinical Manager (CM #1) was queried about documentation of the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. CM #1 was unable to provide the requested data and stated, "We've worked on this, but we don't have anything that's formal and signed off on."

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Governing Body failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 43 patients currently receiving services and all 154 patients admitted over the past year. Findings include: During an interview on 7/1/21 at 11:10 AM, a request was made to review the agency's QAPI report and Governing Body meeting minutes for 2019, 2020 and 2021. Upon receipt and review of the agency's QAPI data, there was no data made available for review that determined or affirmed the Governing Body's oversight of the QAPI program since 2019. These findings were reviewed with and acknowledged by the Clinical Manager who stated, "Again, we've talked about this, but we don't have anything that's official and signed off on."

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on document review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement program (See G 684); and failed to provide infection control education to staff (See G 686). The cumulative effects of these systemic problems resulted in the agency's inability to ensure the provision of safe health care for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control of infectious and communicable diseases including Covid-19 as an integral part of the agency's quality assessment and performance improvement program, and failed to develop a method of screening visitors and staff employed by the agency, resulting in the potential development and spread of the Covid-19 infection between staff and the agency's 43 current patients. Findings include: Upon arrival to the agency on 6/29/21 at 9:00 AM, it was observed that there was no sign posted on the suite door that directed visitors and staff of the protocol for entering the agency. Upon entering the suite, the writer was greeted by the Clinical Manager (CM #1) and escorted to a conference room without first being screened for Covid-19 (temperature check, Covid questionnaire). There was no protocol in place for the screening of visitors. CM #1 was queried on 7/1/21 at 11:20 AM to provide documentation of staff performing Covid-19 screening procedures prior to patient care. No documentation was evidenced, and CM #1 stated, "We don't have anything that was documented to show you." On 7/1/21, the agency's QAPI (quality assessment and performance improvement) program documentation was reviewed for the last 3 years. There was no documented evidence the agency's QAPI program included the surveillance, identification, prevention, or control of Covid-19 or any other infectious and communicable diseases since 2019. CM #1 did produce a document on 7/1/21 at 11:25 AM titled, "Pandemic Infectious Disease, Policy No. (blank)" that was without any signatures authorizing its approval for use. The findings were reviewed with and acknowledged by CM #1 during an interview on 7/1/21 at 11:30 AM.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to provide evidence that Covid-19 infection control education was provided to any staff employed by the agency, resulting in the potential for the development and spread of the Covid-19 infection to staff and all 43 patients currently serviced by this agency. Findings include: On 7/1/21 at 11:20 AM, the Clinical Manager (CM #1) was queried about documentation of staff training, education, and in-services regarding the infection control/Covid-19. CM #1 produced a document at 11:25 AM titled, "Pandemic Infectious Disease, Policy No. (blank)" that was without any signatures authorizing its approval for use. In addition, there was no confirmation that the information had been received or reviewed. CM#1 was then asked if any further educational in-services/training concerning infection control was provided to staff. CM #1 stated, "We don't have any sign in sheets or anything that was documented, so no." The Agency failed to provide infection control education to staff to prevent the probability of the development and spread of the Covid-19 virus.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the clinical record was complete, including assessments, notes and evaluations, for 1 (MR #4) of 1 record with incomplete documentation, from a total of 7 records reviewed, resulting in an incomplete record, an incomplete depiction of the patient's health status, and the potential for unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 6/24/21 with diagnoses that included s/p (status post) CVA (stroke), Hemiparesis and hypertension. During the review of the clinical record on 6/30/21 and 7/1/21, it was noted that the following services were ordered: Speech Therapy (ST), Skilled Nursing (SN) and Physical Therapy (PT). During the review, it was noted that the PT evaluation was left blank. Further review revealed that sections 1021, 1023 and the Psychosocial section of the Initial Comprehensive Assessment were left blank. Neither document had been completed by the end of the survey. These findings were reviewed with the Clinical Manager (CM #1) during an interview on 7/1/21 at 9:17 a.m. who reported, "We've identified this as an issue. With regard to the Comprehensive Assessment, the Nurse (RN #1) was to complete it."

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was complete, provided the patient's health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 1 (MR #6) of 2 closed records; and failed to ensure a transfer summary was sent to the physician/receiving facility within 2 business days of the patient's transfer for 1 of 1 (MR #3) record in which the patient was transferred to an inpatient facility, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of transfer, the physician not having a clear picture of the patient's status at the time of discharge, the potential for unidentified continuing health care concerns and unmet care needs. Findings include: Agency Policy: "Discharge/Transfer Policy" 2.17 (dated 2018) stated, "All transferred patients will have required documentation to ensure appropriate communication is provided to the receiving agency. Relevant information regarding the patient/client's condition and care requirements will be provided verbally and in writing to the facility within 48 hours of the Agency becoming aware of the transfer." Agency Policy: "A written discharge summary, which must be completed, and a copy sent to the physician within 5 business days of discharge, will include: patient identifying information, physician, reason for and date of discharge, status at the time of discharge, patient's diagnosis, summary of the care and services provided, progress toward goals, instructions and referrals provided to the patient..." MR #3: This patient was admitted to the agency on 11/13/20, and a transfer OASIS (outcome and assessment information set) was completed by RN #1 on 11/18/20. Record review on 7/1/21 indicated there was no documented evidence a transfer summary was sent to the receiving facility within 2 business days of the patient's transfer. Further, the transfer OASIS failed to include any history with clinical data, treatments furnished, recent admission (11/9/21)/discharge dates (11/13/21), current medications, and outcomes in meeting goals in the plan of care. These findings were reviewed with and confirmed by the Clinical Manager during an interview on 7/1/21 at 12:10 PM. MR #6: The patient's SOC was 12/12/20 with diagnoses that included insulin dependent diabetes mellitus, epilepsy and gastroparesis. During the clinical record review on 6/30/21 at 11:30 a.m., it was noted that the POC ordered the patient to receive skilled nursing (SN) services. The patient discharged from the agency's services on 12/31/20. The SN "Discharge Summary" dated 12/31/20 was vague and failed to include details of the course of care provided during the period of care with responses to treatment, and stated, "Services provided: Diabetic teaching, med uses, correlation between diet and blood sugar readings..." There was no documentation of baseline and current blood sugar readings, no status of any epileptic seizures, additional needs as appropriate, and no indication of whether the discharge summary was forwarded to the Physician within 5 days of the patient's discharge from the agency's services. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 7/1/21 at 9:49 a.m. who reviewed the SN discharge summary and reported, "There should be a summary of treatment, responses and status at discharge and referrals. I don't see any documentation that it (summary) was forwarded to the Physician."